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IRCT20201221049782N1 IRCT 2021-04-16 Pharmachemie pharmaceutical factory Loratadine in treating irritable bowel syndrome Clinical efficacy and safety of loratadine in treating irritable bowel syndrome with predominant diarrhea 2021-02-28 anticipated 100 Complete https://irct.ir/trial/53859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with IBS-D are randomly divided into a Loratadine group and a control group. random allocation process is done by permuted block randomization. 25 Blocks (with 4 subjects per block and AABB permutations) is made by Randomization.com Website and placed on the same drug packages by coding. Letters A and ‌B, the intended permutation and other required information are entered in randomization website. 100 phrases with letters A or B are achieved, which randomly indicate Who should take loratadine and who should take placebo from the first to the hundredth patient,(A=loratadine ,B=placebo), Blinding description: This is a randomized controlled trial (RCT), In this study, participants, the main researcher, clinicians, the data collector, and the Data Safety and Monitoring Committee are blinded. Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos. The blinded data collector collects data from patients every 2weeks. In the end, the Data collected from both groups are analyzed by data analysts. 3 Irritable bowel syndrome with diarrhea. Intervention 1: Intervention group: The patients in the Loratadine group receive Loratadine tablets(10mg, oral) made by Pharmachemie pharmaceutical company once daily for 4-6 weeks (if patients do not response to the treatment the dose will be increased to 10mg twice daily), also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate). Intervention 2: Control group: Patients in the control group receive oral Placebo made by Pharmachemie pharmaceutical company once daily for 4-6 weeks. also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Lake of time
public Fatere seyedalipour
Medicinal Care unit, first floor, Babol university of medical science, Ganjafrooz street, babol
Babol Iran (Islamic Republic of) 4717641367 +98 11 3223 8301 f_seyedalipour@yahoo.com Babol University of Medical Sciences scientific Fatere seyedalipour
Medicinal Care unit, first floor, Babol university of medical science, Ganjafrooz street, babol
Babol Iran (Islamic Republic of) 4717641367 +98 11 3223 8301 f_seyedalipour@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients with IBS-D Age between 18 and 65 No abnormalities on physical examination Routine CBC No abnormalities observed by Sigmoidoscopy Normal thyroid function Negative routine stool examinations 18 years 65 years Both Diabetes Renal impairment Cardiovascular disorders Psychiatric disorders Colitis Celiac disease Use of drugs that affect the digestive system Use of Analgesics Use of Antihistamines Loratadine intolerance K58.0 Irritable bowel syndrome with diarrhea Treatment - Drugs Treatment - Drugs Intervention group: The patients in the Loratadine group receive Loratadine tablets(10mg, oral) made by Pharmachemie pharmaceutical company once daily for 4-6 weeks (if patients do not response to the treatment the dose will be increased to 10mg twice daily), also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate). Control group: Patients in the control group receive oral Placebo made by Pharmachemie pharmaceutical company once daily for 4-6 weeks. also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate). Diarrhea Frequency. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: questionnaire. Severity of pain. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: questionnaire. Abdominal pain frequency. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: questionnaire. Defecation urgency. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: questionnaire. Bloating. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: questionnaire. Quality of life score. Timepoint: before treatment and 14, 28, 42 and 56 days after beginning of treatment. Method of measurement: Irritable bowel syndrome-Quality of life questionnaire(IBS-QOL). Pharmachemie pharmaceutical factory Approved 2021-01-30 Ethics committee of babol university of medical sciences Babol university of medical sciences, Ganjafrooz street, babol Babol Mazandaran Iran (Islamic Republic of)